Trial record 5 of 8 for:    Open Studies | "Rectal Prolapse"

Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Cantonal Hosptal, Baselland
Sponsor:
Information provided by (Responsible Party):
Daniel Steinemann, MD, Cantonal Hosptal, Baselland
ClinicalTrials.gov Identifier:
NCT01992406
First received: November 12, 2013
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

Natural orifice transluminal endoscopic surgery has become an important topic. NOTES access routes give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transvaginal laparoscopic cholecystectomy and transvaginal anterior resection for diverticulitis show that such NOTES procedures are feasible and safe. The complication rate to conventional laparoscopic procedures is similar. Since transvaginal access is impossible in men, an alternative route is missing. There are experimental studies and small case series reporting the feasibility of transrectal anterior resection. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transrectal hybrid-NOTES anterior resection.


Condition
Sigmoid Diverticulosis
Sigmoid Diverticulitis
Colon Adenoma
Rectal Prolapse

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection

Resource links provided by NLM:


Further study details as provided by Cantonal Hosptal, Baselland:

Primary Outcome Measures:
  • Transanal specimen extraction possible or not [ Time Frame: at surgery ] [ Designated as safety issue: No ]
    Feasibility to remove the specimen (sigmoid colon) through the rectum/anus. If this is not possible during surgery (due to bulky specimen or narrow pelvis) an alternative mini-laparotomy has to be performed.


Secondary Outcome Measures:
  • Number of Participants with postoperative complications (and severity of complications according Clavien-Dindo) [ Time Frame: up to 6 weeks postoperative ] [ Designated as safety issue: Yes ]
    Postoperative complications are recorded and graded according to Clavien-Dindo classification. Complication rates and especially occurence of anastomotic leakage and pelvic sepsis will be compared to the literature of current techniques.

  • continence 6 months postoperative [ Time Frame: 6 months postoperative ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 6 months postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: November 2013
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Transrectal hybrid-NOTES anterior resection

Detailed Description:

Primary endpoint:

To demonstrate in a prospective cohort study the feasibility (specimen extraction through rectum possible to perform or not), safety (complications graded according to Clavien-Dindo) and postoperative outcome (gastrointestinal quality of life questionnaire and anal sphincter manometry) of routine hybrid-NOTES transrectal anterior resection for benign indication in men and women.

Secondary endpoints:

  • quality of life 6 months after surgery
  • continence 6 months after surgery
  • pain postoperative
  • complication rate
  • duration of procedure
  • lengh of stay

Hypothesis:

The investigators expect specimen extraction through the rectum to be feasible in 80% of cases (in the others an alternative mini-laparotomy has to be performed).

study design: This is an open cohort study on 36 patients. The patients are included before surgery and baseline parameters are put in a registry. There are clinical controls 6 weeks, 3 and 6 months postoperative. 3 and 6 months postoperative as well as preoperative a anorectal manometry is performed.

Inclusion criteria:

- benign indication for left sided colectomy.

exclusion criteria:

  • age <18 years
  • patient unable to understand informed consent or missing informed consent
  • emergency surgery

power calculation: A feasibility of 80% with a precision of 15% is estimated. Given a 5% drop out rate 36 patients are to be included in the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with benign indication for left sided colectomy

Criteria

Inclusion Criteria:

  • benign indication for left sided colectomy

Exclusion Criteria:

  • age below 18 years
  • unable to understand informed consent of missing informed consent
  • emergency surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01992406

Contacts
Contact: Daniel C Steinemann, MD +41 61 436 36 36 daniel.steinemann@ksbl.ch
Contact: Sebastian Lamm, MD +41 61 436 36 36 sebastian.lamm@ksbl.ch

Locations
Switzerland
Kantonsspital Baselland, Department of Surgery, Bruderholz Recruiting
Bruderholz, Switzerland, 4101
Contact: Daniel C Steinemann, MD         
Contact: Sebastian Lamm, MD         
Principal Investigator: Daniel C Steinemann, MD         
Principal Investigator: Sebastian Lamm, MD         
Principal Investigator: Andreas Zerz, MD         
Sponsors and Collaborators
Cantonal Hosptal, Baselland
Investigators
Study Chair: Andreas Zerz, MD Kantonsspital Baselland, Department of Surgery, Bruderholz
  More Information

No publications provided

Responsible Party: Daniel Steinemann, MD, Principle Investigator, Cantonal Hosptal, Baselland
ClinicalTrials.gov Identifier: NCT01992406     History of Changes
Other Study ID Numbers: TRANSRECTAL
Study First Received: November 12, 2013
Last Updated: November 19, 2013
Health Authority: Switzerland: Laws and standards

Additional relevant MeSH terms:
Rectal Prolapse
Adenoma
Diverticulitis
Diverticulum
Prolapse
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Rectal Diseases
Intestinal Diseases
Pelvic Organ Prolapse

ClinicalTrials.gov processed this record on July 22, 2014